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Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)

Primary Purpose

Psychosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Asenapine
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Elderly subjects with psychosis Exclusion Criteria: Have an uncontrolled, unstable clinically significant medical condition. Have an established diagnosis of dementia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Asenapine 2-10 mg BID

    Asenapine 5-10mg BID

    Arm Description

    Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)

    Dose titration from 5 mg to 10 mg BID

    Outcomes

    Primary Outcome Measures

    Number of Participants Who Experienced an Adverse Event
    Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).
    Number of Participants Who Discontinued Because of an Adverse Event
    Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax
    Tmax defined as time to peak concentration.
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax
    Cmax defined as peak concentration.
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax
    dn-Cmax is defined as dose normalized peak concentration.
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin
    Cmin defined as pre-dose concentration.
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12
    AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12
    dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 23, 2006
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00281320
    Brief Title
    Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
    Official Title
    A Randomized, Parallel Group, Multiple Dose, 6-Week Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Asenapine in Elderly Subjects With Psychosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluates the safety and tolerability of Asenapine in elderly patients with psychosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    122 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Asenapine 2-10 mg BID
    Arm Type
    Experimental
    Arm Description
    Dose titration from 2 mg to 5 mg to 10 mg twice daily (BID)
    Arm Title
    Asenapine 5-10mg BID
    Arm Type
    Experimental
    Arm Description
    Dose titration from 5 mg to 10 mg BID
    Intervention Type
    Drug
    Intervention Name(s)
    Asenapine
    Other Intervention Name(s)
    Saphris
    Intervention Description
    Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6); or Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6).
    Primary Outcome Measure Information:
    Title
    Number of Participants Who Experienced an Adverse Event
    Description
    Participants who experienced treatment-emergent adverse events, defined as newly reported events after baseline or events reported to have worsened in severity since baseline (from the date of informed consent to the last dose day + 7 days for non-serious adverse events and 30 days for serious adverse events).
    Time Frame
    Up to Day 42 (treatment period)
    Title
    Number of Participants Who Discontinued Because of an Adverse Event
    Description
    Discontinuations due to treatment-emergent adverse events starting on or after Day1 and up to 7 days after study medication stop date (30 days for serious adverse events).
    Time Frame
    up to 30 days after study medication stop date
    Title
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Tmax
    Description
    Tmax defined as time to peak concentration.
    Time Frame
    Day 4 or 8
    Title
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis,Cmax
    Description
    Cmax defined as peak concentration.
    Time Frame
    Day 4 or 8
    Title
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis , Dn-Cmax
    Description
    dn-Cmax is defined as dose normalized peak concentration.
    Time Frame
    Day 4 or 8
    Title
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Cmin
    Description
    Cmin defined as pre-dose concentration.
    Time Frame
    Day 4 or 8
    Title
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, AUC 0-12
    Description
    AUC 0-12 defined as area-under-the-curve from zero to time point 12 hours.
    Time Frame
    Day 4 or 8
    Title
    Pharmacokinetics of Asenapine up to Doses of 10 mg BID in Elderly Subjects With Psychosis, Dn-AUC 0-12
    Description
    dn-AUC 0-12 defined as dose-normalized area-under-the-curve from zero to time point 12 hours.
    Time Frame
    Day 4 or 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Elderly subjects with psychosis Exclusion Criteria: Have an uncontrolled, unstable clinically significant medical condition. Have an established diagnosis of dementia

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21755540
    Citation
    Dubovsky SL, Frobose C, Phiri P, de Greef R, Panagides J. Short-term safety and pharmacokinetic profile of asenapine in older patients with psychosis. Int J Geriatr Psychiatry. 2012 May;27(5):472-82. doi: 10.1002/gps.2737. Epub 2011 Jul 13.
    Results Reference
    result

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    Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)

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